None listed
Conditions
Brief summary
This study aims to describe real-world clinicopathologic presentation and treatment selection in routine care of patients with recently diagnosed metastatic colorectal cancer that have a biomarker of interest. Who is it for? You may be eligible to join this study if you are aged 18 years and older with any ECOG performance status and with histologically confirmed metastatic colorectal cancer (either de novo metastatic or relapsed) that harbour at least one of these biomarkers of interest after 1st January 2021. Study details All participants who meet the eligibility criteria in this study will have their data collected on specific biomarker. During and after completion of the Metastatic colorectal cancer treatment participants data will be collected on biomarkers, progression free survival, overall survival, medical access, and disease free interval. It is hoped that this research project could help answer research questions around assessing the incidence, clinicopathologic associations, variation in treatment management and outcomes in routine care.
Interventions
The TRACC-SELECT study is a non-interventional registry designed for prospective data collection on specific biomarker defined subsets of patients with metastatic colorectal cancer. The indication for the registry are patients with recurrent and/or metastatic colorectal cancer with biomarkers of particular interest, including but not limited to deficient MMR, BRAF V600E mutant, KRAS G12C mutant, HER2, POLE and/or NTRK.
From each sub-group, an initial 25-50 patients will be enrolled from 10-15 si
The TRACC-SELECT study is a non-interventional registry designed for prospective data collection on specific biomarker defined subsets of patients with metastatic colorectal cancer. The indication for the registry are patients with recurrent and/or metastatic colorectal cancer with biomarkers of particular interest, including but not limited to deficient MMR, BRAF V600E mutant, KRAS G12C mutant, HER2, POLE and/or NTRK. From each sub-group, an initial 25-50 patients will be enrolled from 10-15 sites in Australia. Recruitment will take place over a 10 year period from 2022 with a study end date of December 2032. There is no direct involvement by patients and all data is collected from the patient medical record. The data collected will include patient characteristics, tumour characteristics, treatment for metastatic disease and molecular analysis as described above.
Sponsors
The Walter and Eliza Hall Institute of Medical Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients eligible for enrolment on to study must meet the following criteria: 1. Patients greater than or equal to 18 years of age, with any Eastern Cooperative Oncology Group (ECOG) performance status and with histologically confirmed metastatic colorectal cancer (either de novo metastatic or relapsed) that harbour at least one of these biomarkers of interest a) Deficient mismatch repair proteins (dMMR) b) BRAF V600E mutation c) KRAS G12C mutation d) HER2 ISH positive e) NTRK fusion (either IHC positive or NGS positive) f) POLE mutation g) FGFR2 amplification 2. Diagnosed with metastatic colorectal cancer after 1st January 2021 NB: Written informed consent from patients is not required for this study
Exclusion criteria
Diagnosed prior to 1st January 2021
Outcome results
None listed